Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).

Device Description

Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Coamatic® LR Antithrombin device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Metric (If available)	Acceptance Criteria	Reported Device Performance	Comments
Method Comparison	Slope	N/A	1.011	The correlation with the predicate device is excellent, indicating high agreement.
	Intercept	N/A	0.4889
	Correlation coefficient (r)	N/A	0.995	This value is very close to 1, demonstrating a strong linear relationship.
Precision	Within-run CV% (114% AT)	N/A	1.96%	Excellent precision at high AT levels.
	Within-run CV% (59% AT)	N/A	6.21%	Good precision at mid AT levels.
	Within-run CV% (29% AT)	N/A	8.45%	Acceptable precision at low AT levels, though slightly higher than at other levels.
	Total CV% (114% AT)	N/A	3.52%	Excellent overall precision at high AT levels.
	Total CV% (59% AT)	N/A	6.43%	Good overall precision at mid AT levels.
	Total CV% (29% AT)	N/A	11.09%	Acceptable overall precision at low AT levels.

Note: The document does not explicitly state pre-defined numerical "acceptance criteria" for the slope, intercept, r-value, or CV%. Instead, it presents the results from which the FDA made a substantial equivalence determination based on the overall performance compared to the predicate device. The values presented here are the "reported device performance."

Study Details

2. Sample Size and Data Provenance

Sample Size for Test Set: 61 citrated plasma samples.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Not Applicable (N/A): This type of information is usually relevant for medical imaging or AI diagnostic devices where human experts interpret data. For an in vitro diagnostic (IVD) assay like this, the "ground truth" is typically established by a reference method or validated analytical procedure rather than human expert consensus. The comparison is made against the predicate device.

4. Adjudication Method for Test Set

Not Applicable (N/A): Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, which is not relevant for this type of IVD device study. The comparison is objective, based on analytical measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study is primarily for medical imaging devices where different human readers evaluate cases with and without AI assistance. This device is an automated IVD assay.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The "Method Comparison" section directly assesses the performance of the Coamatic® LR Antithrombin assay on the ACL Futura against the predicate device (IL Test™ Liquid AT) on the ACL 9000. This is a direct measurement of the device's performance as an algorithm/test system. The "Precision" study also assesses the standalone analytical performance of the device on the ACL Futura.

7. Type of Ground Truth Used

Predicate Device/Reference Method: The "ground truth" or reference for comparison was the IL Test™ Liquid Antithrombin on the ACL 9000, which is the legally marketed predicate device. This implies that the predicate device is considered the established method for determining Antithrombin levels in this context.

8. Sample Size for Training Set

Not Applicable (N/A): The document describes a traditional analytical validation for an IVD assay, not a machine learning or AI-driven device that requires a training set. The device itself is a reagent kit and instrument system.

9. How Ground Truth for Training Set Was Established

Not Applicable (N/A): As there is no training set mentioned or implied for a machine learning algorithm, this question is not relevant.

Summary

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AUG 2 7 2002

IC022552

Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207

Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

August 1, 2002

Name of the Device:

Coamatic® LR Antithrombin

Classification Name(s):

864.7060	Antithrombin III Assay	Class II
81JBQ	Antithrombin III Quantitation

Identification of Predicate Device(s):

K994238 IL Test™ Liquid Antithrombin

Description of the Device/Intended use(s):

Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

Coamatic® LR Antithrombin is substantially equivalent in performance to the predicate device: IL Test™ Liquid Antithrombin

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Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In a method comparison study evaluating 61 citrated plasma samples with Antithrombin levels ranging in value from 8.6% to 121.5% AT activity, the correlation statistics for Coamatic® LR Antithrombin on an ACL Futura versus the predicate device on an ACL 9000 are shown below:

System	Slope	Intercept	r	Reference Method
ACL Futura	1.011	0.4889	0.995	IL TestTM Liquid AT on ACL 9000

Precision

Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results:

ACL Futura
Mean (% AT)	CV% (Within run)	n	CV% (Total)	n
114	1.96	6	3.52	60
59	6.21	6	6.43	60
29	8.45	6	11.09	60

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.

Food and Drug Administration 098 Gaither Road Rockville MD 20850

AUG 2 7 2002

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125

K022550 Re: Trade/Device Name: Coamatic® LR Antithrombin Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBO Dated: August 1, 2002 Received: August 2, 2002

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coamatic® LR Antithrombin

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign/Off)
Division of Clinical Laboratory Devices	K022550
510(k) Number

Prescription Use __________ OR Over-The-Counter Use __________

(Per 21 CFR 801.019)
Coamatic® LR Antithrombin 510(k)

Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).